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Filgotinib oral


Oral formulations of filgotinib.

Drugs List

  • filgotinib 100mg tablets
  • filgotinib 200mg tablets
  • JYSELECA 100mg tablets
  • JYSELECA 200mg tablets
  • Therapeutic Indications


    Moderate to severe active rheumatoid arthritis-other regimens unsuitable

    Treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
    Filgotinib can be used as monotherapy or in combination with methotrexate.



    200mg once daily.


    Patients aged 75 years and over: 100mg once daily. The dose may be increased to 200mg once daily if the particular clinical circumstance of the patient has been considered.

    Patients with Renal Impairment

    Creatinine clearance 15 to less than 60ml/minute: 100mg once daily.


    Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
    Children under 18 years
    Haemoglobin concentration below 8g / dL
    Neutrophil count below 1.0 x 10 to the power of 9 / L at baseline
    Severe infection
    Renal impairment - creatinine clearance below 15ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Females of childbearing potential
    History of recurrent infection
    Patients over 75 years
    Predisposition to infection
    Predisposition to venous thromboembolism
    Prolonged immobilisation
    Glucose-galactose malabsorption syndrome
    History of tuberculosis
    History of venous thromboembolism
    Lactose intolerance
    Malignant neoplasm
    Moderate renal impairment

    Administration of live vaccines is not recommended
    Before initiating screen all patients for viral hepatitis
    Interrupt therapy if herpes zoster occurs
    Advise patient dizziness may affect ability to drive or operate machinery
    Avoid concurrent use of immunosuppressants
    Before starting therapy ensure immunisations are up to date
    Monitor patients for non-melanoma skin cancer prior to and during treatment
    Prior to starting therapy screen for latent tuberculosis
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Monitor for and manage hepatitis reactivation during treatment
    Monitor patient for signs of serious infection
    Monitor serum lipids 3 months after initiation
    Monitor serum lipids in patients with hyperlipidaemia
    Advise patient to seek med advice if signs/symptoms of tuberculosis develop
    Immunosuppressive drugs may increase risk of malignancy
    Interrupt if haemoglobin falls below 8 g/dL
    Interrupt if lymphocyte count less than 0.5 x 10 to the power of 9/L
    Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
    Interrupt treatment if severe infection develops
    Discontinue if symptoms of deep vein thrombosis occur
    Discontinue if symptoms of pulmonary embolism occur
    Male: May cause infertility
    Female: Contraception required during and for 1 week after treatment

    Pregnancy and Lactation


    Filgotinib is contraindicated during pregnancy.

    The manufacturer advises that filgotinib may cause foetal harm and should not be used during pregnancy. Animal studies have shown reproductive toxicity.


    Filgotinib is contraindicated during breastfeeding.

    The manufacturer advises that filgotinib should not be used during breastfeeding as it is unknown whether it is excreted in human milk. A risk to newborns/infants cannot be excluded.

    Side Effects

    Creatine phosphokinase increased
    Deep vein thrombosis (DVT)
    Herpes zoster
    Pulmonary embolism
    Upper respiratory tract infection
    Urinary tract infections


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2022

    Reference Sources

    Summary of Product Characteristics: Jyseleca 100mg film-coated tablets. Gilead Sciences Ltd. Revised December 2021.
    Summary of Product Characteristic: Jyseleca 200mg film-coated tablets. Gilead Sciences Ltd. Revised December 2021.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.